Here is the most efficient way to develop, manufacture,
and market your R&D seeds in Japan
A Shortcut to Out-Licensing and Commercialization of Research Seeds
Do you know that the development of drugs and medical devices in Japan requires, in principle, clinical development in Japanese subjects? CUES Consulting Inc. is a consulting firm that provides support for pharmaceutical and medical device development, regulatory submissions, and post-marketing activities in Japan, which can be difficult for foreign companies that do not yet have a branch office in Japan or do have a branch office but do not have sufficient staff. With our extensive experience, we can help you commercialize your R&D seeds in Japan more efficiently and with less risk than anyone else.
Consulting Service
Post-Marketing Pharmaceutical Service
Safety Management Service
OUR SERVICE
What does CUES Consulting exactly offer you?
Various business supports for early and reliable commercialization of
R&D seeds and the risk management
1. Comprehensive support for bio-venture companies
General consulting on management system development (organization, governance, BCP planning, etc.)
Complement missing skill sets (regulatory affairs, preclinical and clinical development, quality change management, safety management, COO)
Development strategy planning and general regulatory support from the early stage of development
Preparation and maintenance of various SOPs and CRO management on behalf of the company
Application for marketing approval and dealing with authorities
2. Risk management
Fast commercialization and support for operations of the three Responsible Officers* based on risk management.
Obtaining a marketing authorization license
Develop an effective internal system centered on the General Marketing Supervisor
Appropriate change control of products (Closing the CMC Gaps)
Efficient safety information management using the company’s own safety database
Safety assurance measures based on global standards
Operational support for crisis management such as product recall, emergent safety communication (Yellow Letter/Blue letter*), etc.
What is the “Three Responsible Officers” support ?
In Japan, MAHs are required to assign a "General marketing Supervisor, Quality assurance officer, and Safety Management officer" (so-called "three officers") to ensure proper quality and safety management of pharmaceutical products.
Since it may not be easy to recruit responsible persons who understand the Pharmaceutical Affairs Law and other regulations and have sufficient experience, CUES's experienced consultants will support all or part of the duties of the “three responsible officers” to ensure smooth and appropriate operations.
What is a “Yellow Letter/Blue Letter?”
The important safety information which are prepared by companies based on instructions from the MHLW when it is judged that urgent safety measures need to be taken.
“Dear Healthcare Professional Letter” (Yellow Letter) contains emergent and important safety information about drugs and medical devices.
“Dear Healthcare Professional Letters of Rapid Safety Communications” (Blue Letter) is second in importance to the yellow letter that contains information to be promptly provided to alert healthcare professionals.
3. Other consulting services
Consulting
Conduct work analysis and operational improvement for safety management operation efficiency
Support various consultations with the authorities and preparations of responses to inquiries
Support obtaining and renewing the authorization of manufacturing and distribution
Prepare various SOP
Construct CTD2.7 and package insert draft
Others
Safety Management
Accept whole medicine and medical device’s safety management operation
Collect, analyze and measure safety management information (adverse event)
Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing)
Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report
Post-Marketing Pharmaceutical
Construct package insert and related documents
Correspond inquiry matters from authorities
CMC pharmaceutical operation
Support certificate of approval
Support drug price calculation process
REASON & BUSINESS FLOW
Why are we chosen?
1. Deeply Experienced Consultants
A consultant with solid experiences in Japan is indispensable to quicky and reliably reach the business goal, such as licensing out and commercialization in Japan. CUES has more experienced consultants in Japan than any other consulting firm.
CUES CONSULTANTS
Representative Director
Motoyuki TAKANO
Daiichi Pharmaceutical, Wyeth, Sanofi, Shire, Ferring, Medtronic
Clinical Development Project Leader (Cardiovascular, CNS) / Safety Management Officer / Manager of planning safety assurance measures / Head of Pharmacovigilance dept. / Advanced Medical Device Safety Management
Due diligence (evaluation of in-licensed products) / Development planning / Project management / Transfer of safety data at the time of succession / Introduction of safety information management system
Chairman
Takashi YOSHIDA
Fujisawa Pharmaceutical, Astellas, Sanofi, GSK
Regulatory Affairs / Clinical Development (3 years in the U.S.) / Executive Officer & General Manager of Regulatory Affairs / General Manager of Reliability Assurance Division / Head of Public affairs / Director of Global Regulatory Affairs, Japan & Asia Pacific / Executive Officer, General Marketing Supervisor
Regulatory affairs (development and post-marketing pharmaceutical affairs) / Risk management (product recall, blue letter) / Corporate mergers, Product succession, Due diligence
External expert panelists:
Medical writer, Preclinical evaluation, Safety evaluation, CMC regulatory affairs, / Public relations (NHI drug pricing),Medical expert, / Advanced medical device development, Overseas business consultant
2. A One-Stop Service is Available.
CUES can provide one-stop services for the entire value chain and supply chain, from company start-up in Japan to post-marketing.
One-stop service from development to post-marketing
Drawing the development strategy from pre-clinical to post-marketing
Strategic proposals for dealing with authorities Applications for approval, and answering to PMDA questions
Various supports for obtaining business licenses
Appropriate post-marketing quality change management and Safety management supports
Business proposals for efficiency, resource/risk reductions
3. Advantages of Being an Elite Few
CUES is a small, elite organization that runs the firm, including the President and Chairman doing the consulting themselves. Do you know what that means? Well, unlike large consulting companies and CROs, there are no overhead costs added on, which makes it possible to set reasonable prices.
4. Extensive experience in negotiating with the MHLW and PMDA(health authority)
We are proud of our experience in regulatory affairs for numerous pharmaceutical and medical device manufacturing and sales companies. It is a well-known fact that negotiating with Health Authorities in any country requires experience and skill, and CUES consultants know their negotiating partners well and are skilled in tactics and negotiation based on experience. This means that your seeds can be commercialized quickly and reliably, with low budget, through licensing and sales.
5. Familiar with How to Obtain a Manufacturing and Sales License in Japan
In order to sell pharmaceutical products and medical devices in Japan, it is necessary to obtain a business license from the Local Authority and to build an organization to do so, in addition to obtaining marketing approval or certification from the Ministry of Health, Labor and Welfare. We are not only familiar with the process and procedures, but can also assist you in building an organization that includes the three positions required to obtain the license, and can also perform some or all of the other roles on your behalf.
6. Logical and Unified Consultation
We will work diligently and sincerely to address the following matters and strive to resolve them while sharing the joy of working with stakeholders involved in these efforts, thereby contributing to the grow of Japan's healthcare industry.
We provide consulting services that are closely aligned with the client's position and situation, and provide a sense of unity.
We provide precise and value-added solutions to the various challenges faced by clients with insufficient resources and experience.
We deliver results that will build lasting relationships and the bond of trust.
7. Supporting the Corporate Risk Management
In Japan, if a company causes quality issues or delays in reporting side effects, it may be subject to a business suspension or business improvement order from the Ministry of Health, Labor and Welfare. We cannot neglect efforts to minimize management risks, such as the development of SOPs to ensure compliance with management governance systems and compliance.
CUES faces these business risks and helps companies to contribute to healthcare in a healthy way.
8. Opening Sales Opportunities
The aforementioned CUES's strengths will help you generate business efficiently on your seeds. This means to you that your seeds will have a higher and faster ROI (Return on Investment) in Japan.
REASON
Why are we chosen?
Why are
we chosen
Assisting entire
3 manufacturing roles
1Assisting entire 3 manufacturing roles
We will assist the three operation roles, Marketing supervisor general・Quality assurance manager・Safety supervisor. This is a new service that was never before covering everything from establishing venture companies to safety management after marketing. We will assist from everything.
Highly
specialized staff
High cost
performance
Global standard
quality
FLOW
Operational flow
Operation term
From inquiry to estimation
⇒ about 1 week
• When consulting/ creating application form etc.
⇒ Earliest as 1 week~ after agreement
• When using safety database
⇒ Earliest as 3 months ~
01
Inquiry
AContact us from the inquiry form or by phone.
02
Reviewing
APerson in charge will contact you and review your current situation and requests.
03
Proposal・Estimation
AWe will propose the estimation and the best plan from reviewing the customer’s needs.
04
Contract・Place an order
BWe will execute necessary contracts after placing the order.
05
Offering services
BWe will operate the services discussed in the proposal.
06
Confirmation・Delivery
Please confirm the final products.
It will be delivered after any modification.
07
Payment
We will close at the end of delivered month and issue the invoice. Please pay by the end of the following month.
ABOUT
Aiming to become the best partner for medicine and medical equipment manufacturer
With high expertise, the experienced Marketing supervisor general
・Safety supervisor staff will answer all the diverse requests and reduce customer’s operation.
| Company Name | CUES Consulting Inc. |
|---|---|
| Representative | Motoyuki TAKANO |
| Address | 6-2-6 Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan |
| URL | https://cues.or.jp/en-top/ |
| Our Services |
1.Consulting Service Construct work analysis and operational improvement for safety management operation efficiency Advise and interview support for responding inquiry matters to authorities Support obtaining and renewing the authorization of manufacturing and distribution Prepare various SOP Construct CTD2.7 and package insert draft Others 2.Safety Management Service Accept whole medicine and medical device’s safety management operation Collect, analyze and measure safety management information (adverse event) Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing) Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report 3.Post-Marketing Pharmaceutical Service Construct package insert and related documents Correspond inquiry matters from authorities CMC pharmaceutical operation Support certificate of approval Support drug price calculation process |
| Clients | Pharmaceutical companies, medical device companies, venture companies |
| Mission Statement | We work sincerely and faithfully to solve the problems of venture companies that lack resources such as people and money, and are struggling to develop product development strategies in the medical industry, while sharing the joy of working with the stakeholders involved in these efforts |
| Access | By train transportation: 3 minute walk from JR Chuo line, Marunouchi subway line, Nanboku subway line “Yotsuya Station” / 5 minute walk from Yurakcho subway Line “Kojimachi Station” |
PRIVACY POLICY
CUES Consulting Inc. (hereinafter referred to as “we” or “our”) will provide and disclose the Personal Information Protection Policy and promote protection of personal information by having all employees as well as our concerned personal follow and understand the importance of the Personal Information Protection Policy.
Proper collection of personal informationWe will collect personal information with a proper procedure and will announce or notify the purpose of use clearly in advance.
Purpose of using personal informationWe will use the personal information that are collected from customers only for contacting, introducing the business and documents, responding to the questions and informing the seminar by sending emails and mails.
Prohibition of disclosure and provision of personal information to third parties
We will properly manage all personal information and will not disclose to any third parties except in one of the following cases.
1-When agreed by the customer.
2-When we outsource the business to the concerned personal to proceed the customer’s request and when required to disclose by the law.
3-When requested from public institutions such as the court, public prosecutor’s office and any law enforcement agencies by statue.
4-When a government or local organization, or an entrusted personal are needed for cooperation in order to proceed the affairs prescribed by law and regulations and when it is recognized that obtaining the person’s consent on the submission of personal data by cooperating government or local organization, or an entrusted personal are likely to impede the execution of the affairs concerned.
5-When especially needed for improving public hygiene or promoting children’s healthy development and when difficult to obtain the personal’s agreement.
6-When the customer or the third party’s life, body, property and reputation are in risk and when we cannot obtain the personal’s agreement.
7-When our rights, properties or services are needed protection or defense from the violation act of the law or our user policy and precautions and when we cannot obtain the personal’s agreement.
8-When provision of personal information is needed for combined, succession or joint ownership of the business in any reasons.
Management of personal information We will maintain the personal information accurately and most up-to-date and to prevent personal information’s unauthorize access, loss, damage, manipulation and leakage, we will take necessary security measures such as to sustain security systems, develop management system and thoroughly train employees to strictly manage personal information.
Security measures of personal information We are implementing all possible security measures to insure the personal information’s accuracy and safety.
Request of personal’s disclosure When the customer request to disclose, revise, suspend the use, or delete their personal information, we will proceed with confirming the subject.
Review and comply the law and norm We will obey any law or other norms regarding the retaining personal information and appropriately review and improve this policy’s contents.
Release and Revision We will indicate the release start date using A.D., descript the public announcement date and make sure to date the revised date clearly.
About cookies Our website uses cookies. Cookie is the user’s information data stored inside the user’s hard disk. The cookie used for our website does not connect with the personal specification information. The website can be used without an issue when rejecting the use of the cookie.
About logfile We adopt logfile to manage the website, analyze the tendency of use, detect the user trend and to obtain congregative and broad demography information. The information gathered from logfile are not connected to the personal specification information.
About link with other websites Our website includes links to other website, but it will not share any personal information. Please refer to the link website for handling personal information. We will not take any responsibility regarding the website’s contents.
For inquiries regarding the handling of personal information, contact us using the information below.
CUES Consulting Inc.
6-2-6 Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel：03-6803-6361 (Representative)
E-mail：info@cues.or.jp
Enactment date：January 24, 2022
CUES Consulting Inc.
Representative Director Motoyuki TAKANO